To Evaluate 2 Doses of GSK Biologicals’ Oral Live Attenuated Human HRV Vaccine co-Administered With Either OPV or IPV - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00346892

Purpose

"The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines.

The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."

Condition	Intervention	Phase
Rotavirus Infections	Biological: Rotavirus (vaccine)	Phase II

MedlinePlus related topics: Polio and Post-Polio Syndrome Rotavirus Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Reactogenicity & Immunogenicity Study of Two Doses of GSK Biologicals’ Oral Live Attenuated HRV Vaccine co-Administered With Either OPV or IPV in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Seroprotection for each polio serotype 1 month after the 3rd dose.

Secondary Outcome Measures:

Proportion of subjects with vaccine take 1 month after each dose of study vaccine, viral shedding in a subset of subjects, presence of RV in diarrheal stools, anti-rota IgA antibody seroconversion rate and serum anti-rota IgA antibody concent

Estimated Enrollment:	450
Study Start Date:	November 2001

Detailed Description:

The study had three groups: Group A: HRV + OPV + DTPa/Hib; Group B: HRV + placebo OPV + DTPa-IPV/Hib; Group C: HRV Placebo + OPV + DTPa/Hib. Two cohorts: Subjects enrolled before the 2002 RV season were to receive two doses of HRV or placebo at approximately 6 and 10 weeks of age (first cohort) and subjects enrolled after the 2002 RV season received vaccinations at approximately 10 and 14 weeks of age (second cohort). Routine EPI vaccinations were to be administered concomitantly with the study vaccines.

Eligibility

Ages Eligible for Study:	5 Weeks to 10 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria: Healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject’s mother during pregnancy or thereafter. Exclusion criteria: History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346892

Locations

South Africa

Pretoria, South Africa

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Study ID Numbers:	444563/014
Study First Received:	February 3, 2006
Last Updated:	September 22, 2006
ClinicalTrials.gov Identifier:	NCT00346892
Health Authority:	South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:

Prophylaxis rotavirus

Study placed in the following topic categories:

Virus Diseases
Rotavirus Infections
Healthy

Additional relevant MeSH terms:

RNA Virus Infections
Reoviridae Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009